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NCT Number: NCT02992457

Safety and Efficacy of Sofosbuvir-Based Regimens in the Treatment of Egyptian Patients With Hepatitis C Infection

Egypt has the highest prevalence of hepatitis C virus (HCV) in the world, estimated nationally at 14.7%. Genotype 4 (and subtype 4a in particular) dominates the HCV epidemic in Egypt. For decades the antiviral therapy of chronic HCV infection was based on the administration of Interferon(IFN), initially alone and then in combination with Ribavirin (RBV), but this regimen was effective in only 50% of patients with genotype 1, with significant side effects.

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Key information

Conditions

Hepatitis C Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Virus Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sherief Abd-Elsalam, Tanta, Egypt

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About this study

Egypt has the highest prevalence of hepatitis C virus (HCV) in the world, estimated nationally at 14.7%. Genotype 4 (and subtype 4a in particular) dominates the HCV epidemic in Egypt. For decades the antiviral therapy of chronic HCV infection was based on the administration ofInterferon(IFN), initially alone and then in combination with Ribavirin (RBV), but this regimen was effective in only 50% of patients with genotype 1, with significant side effects. The introduction of direct acting antiviral agents, in particular sofosbuvir (SOF), has revolutionized the treatment for chronic hepatitis C virus.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • • HCV infection
  • Adult patients, 18years and older.

Exclusion criteria

  • • Child score > 12
  • Severe Renal impairment
  • Pregnant and lactating women
  • HCC or other malignant neoplasms
  • Co-infection with human immunodeficiency virus (HIV)
  • Co-infection with hepatitis B virus (HBV)

Treatment and study plan

Sofosbuvir

Drug

Sofosbuvir 400 mg daily.

Other names: sovaldi , mpiviropack

Ribavirin

Drug

Ribavirin 1000-1200 mg daily

Other names: Rebetol, Riba

Pegylated-interferon alfa-2a

Drug

Pegylated interferon alfa-2a once weekly for 3 months

Other names: peginteron, pegasys

Simeprevir

Drug

Olysio once daily.

Other names: Olysio

Daclatasvir

Drug

Dakla once daily for three months.

Other names: Daklatasvir, Dakla

Ritaprevir, paritaprevir, ombetasvir

Drug

Querevo for three months

Other names: querevo

Sofosbuvir and Ledipasvir

Drug

Once daily for three months

Other names: Harvony

Salvage therapy

Drug

three months in repeated treatment failure

Other names: Sofosbuvir,simeprevir, daclatasvir, ribavirin or sofosbuvir and querevo

Primary outcomes

  1. Number of patients with sustained virological response.

    Time frame: 2 months

    The number of patients achieving SVR

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

Study of the Safety and Efficacy of Sofosbuvir-Based Regimens in the Treatment of Egyptian Patients With and Without Post-hepatitis C Cirrhosis

Important dates

Study start
2015
Primary completion
2018
Study completion
2019
First posted
Dec 14, 2016
Registry last updated
Aug 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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